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PDF Statement on Today's FDA Hearing on Rasagiline (Azilectģ)

- Oct 17 2011

This bulletin is part of a series of occasional reports from the Parkinson’s Disease Foundation (PDF), designed to provide updates and guidance on living with Parkinson’s disease, including medical matters. This particular communication involves an important Parkinson’s medication issue that you may have seen reported in recent news announcements and commentaries.

Teva Pharmaceutical Industries, Ltd., the company that manufactures rasagiline (Azilect®) has asked the U.S. Food and Drug Administration (FDA) to approve a change in label for the drug stating that the drug has been shown to “slow the clinical progression” of Parkinson’s. The medication is currently on the market for the treatment of the signs and symptoms of Parkinson’s – both by itself, as initial therapy, and taken in conjunction with levodopa, as therapy in the later stages of disease progression.

If the request were to be granted, Azilect would be the first drug to receive such a label, a momentous development for our community. Today, Monday, October 17, the FDA will hold a hearing – a Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee – to hear public commentary on this request.

PDF and its scientific advisors, along with the leaders of five other leading Parkinson’s (the American Parkinson Disease Association; the Michael J. Fox Foundation for Parkinson’s Research; the National Parkinson Foundation; the Parkinson’s Action Network; and the Parkinson Alliance) have studied the matter at some length and prepared a joint statement that was presented in writing to the Advisory Committee, and will be introduced today by Amy Comstock Rick, the CEO of the Parkinson’s Action Network, which represents the Parkinson’s community in Washington, DC.

The statement includes this key passage:

“While we are encouraged by the evidence [on the potential of Azilect to slow the progression of Parkinson’s] presented to date, it appears to our community that the data surrounding Azilect as a therapy that slow clinical progression of Parkinson’s are not yet definitive, and that additional information is required to completely determine the impact of Azilect on clinical disease progression.”

Robin Anthony Elliott, PDF’s Executive Director, said he believes that the community-wide response “is an example of one of the most important roles that not-for-profit advocacy groups can play. It is the opportunity and responsibility of PDF and its colleague organizations to speak up on behalf of the community of people who live with Parkinson's when decisions may impact treatments for that community.

“Our philosophy at PDF, quite simply, is that the process of clinical research will be more productive, more economical and more respectful if the voices of people with Parkinson’s themselves, informed by the science, are able to be present at all the key discussion and decision points of the process.”